El efecto de la división sobre la calidad y la liberación in vitro del clorhidrato de metformina de las tabletas de liberación prolongada (XR)

Autores/as

DOI:

https://doi.org/10.33448/rsd-v10i11.19348

Palabras clave:

Metformina; Liberación de fármacos; Disolución; Control de calidad; Diabetes mellitus.

Resumen

El clorhidrato de metformina (MetCl) se utiliza en todo el mundo para el tratamiento de la diabetes mellitus tipo 2. Aunque se comercializan tabletas de liberación prolongada (XR) que contienen 500 mg, 850 mg y 1000 mg de MetCl, no es raro dividir la tableta cuando la forma de dosificación de la concentración requerida no está disponible comercialmente. El objetivo del trabajo fue evaluar los efectos de la división en el rendimiento in vitro de tabletas XR que contienen MetCl. Realizamos ensayos de control de calidad y estudios comparativos de perfil de disolución entre varios medicamentos que contienen 500 mg y 1000 mg de MetCl, comercializados en Brasil y Argentina. Las tabletas que contenían 1000 mg de MetCl se dividieron a la mitad (muestras de prueba) y se compararon con tabletas enteras de productos que contenían 500 mg de MetCl (muestras de referencia). Las tabletas partidas a la mitad eran más frágiles y presentaban menor uniformidad de masa y unidad de dosificación en comparación con las enteras. Sin embargo, el parámetro de arranque F2 demostró que la división de las tabletas de MetCl XR no tuvo un impacto significativo en los perfiles de liberación de fármacos in vitro en comparación con las tabletas completas. Además, ni el mecanismo de liberación del fármaco ni la cinética de liberación se vieron afectados significativamente. Las tabletas XR que contienen 1000 mg de clorhidrato de metformina podrían ser elegibles para la división, sin embargo, los fabricantes deber proporcionar surcos apropiados en las superficies de las tabletas para que la división sea adecuada y más segura para los pacientes.

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Publicado

04/09/2021

Cómo citar

SANTOS, L. G. da F.; SEGALL, A. I. .; KI HAN, Y.; KIZELMAN, M. P.; FERREIRA, M. P. .; SILVA, A. C. F. .; MARTINS, F. S. .; CASTRO, W. V. de .; FREITAS, O. de; COUTO, R. O. do. El efecto de la división sobre la calidad y la liberación in vitro del clorhidrato de metformina de las tabletas de liberación prolongada (XR). Research, Society and Development, [S. l.], v. 10, n. 11, p. e368101119348, 2021. DOI: 10.33448/rsd-v10i11.19348. Disponível em: https://rsdjournal.org/index.php/rsd/article/view/19348. Acesso em: 25 dic. 2024.

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Sección

Ciencias de la salud